NOTICE: Applications submitted in response to this
Funding Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF 424 (R&R)
SBIR/STTR Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application
guidelines included with this announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and
should be started at least two weeks in advance of the planned submission.
See Section IV.

Complex and large-scale socio-behavioral surveys related
to adult health and aging are being developed all over the world. The demand
for new, innovative technologies such as computer assisted interviewing, incorporation
of biological and physiological measures, and user-friendly longitudinal databases
associated with this trend has been expanding for several years. Longitudinal
surveys often become more difficult to use over time due to increased complexity
in the composition of the sample and/or the addition of new survey components,
coupled with inconsistent data files and inadequate documentation. User friendly
data use files are of interest not only to academic researchers, but to insurers,
health care providers, HMOs, pharmaceutical companies and policy analysts.

The purpose of this FOA is to encourage small businesses
to develop the following areas via the STTR (R41/R42) mechanisms:

Awards issued under this FOA are contingent upon the
availability of funds and the submission of a sufficient number of meritorious
applications. Applicants will be solely responsible for planning, directing, and executing
proposed projects.

This FOA will utilize the STTR (R41/R42) grant mechanisms
for Phase I, Phase II, and Fast-Track applications and runs in parallel
with a FOA of identical scientific scope, PA-06-465 that solicits applications under the Small Business Innovation Research
(SBIR) (R43/R44) grant mechanisms.

Eligible organizations: Only United States Small Business
Concerns (SBCs) are eligible to submit STTR applications. A SBC is one that,
on the date of award for both Phase I and Phase II funding agreements, meets
ALL of the criteria as described in Section
III.

Eligible individuals: Any individual with the skills,
knowledge, and resources necessary to carry out the proposed research is
invited to work with his/her organization to develop an application for
support. Individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are always encouraged to apply for NIH
support. On an STTR application, the Project Director/Principal Investigator
(PD/PI) may be employed with the SBC or the participating non-profit research
institution as long as he/she has a formal appointment with or commitment
to the applicant SBC, which is characterized by an official relationship
between the small business concern and that individual.

Applicant SBCs may submit more than one application,
provided each application is scientifically distinct.

See Section
IV.1 for application materials. The SF424 (R&R) SBIR/STTR Application
Guide for this FOA is located at these Web sites:

The National Institute on Aging (NIA) has supported the development of major
longitudinal survey data collection efforts and behavioral interventions in
areas such as cognition, genetics, long term care, retirement and economic
status, caregiving, behavioral medicine, and the dynamics of health and functional
change at older ages. See http://www.nia.nih.gov/NR/rdonlyres/7AE4D0D9-9DF7-4DF4-B8B9-468F19106E23/0/PubliclyAvailDatasetsJul_2006B.pdf
for descriptions of publicly available databases for aging-related secondary
analyses supported by the NIA

In February 2003 NIH reaffirmed its support for the concept
of data sharing and stated that data should be made as widely and freely available
as possible while safeguarding the privacy of participants, and protecting
confidential and proprietary data (https://grants.nih.gov/grants/policy/data_sharing/index.htm).
Many datasets were assembled prior to the implementation of this policy and
although they have been archived, they have not been made available to the
research community in user-friendly formats. Longitudinal surveys often become
more difficult to use over time due to increased complexity in the composition
of the sample and/or the addition of new survey components. In addition, the
formats of the data files and the documentation are not always consistent
across the survey years. Socio-behavioral surveys are being used all over
the world by continuously expanding research and policy communities.
User friendly, data use files could be of interest not only to academic researchers,
but to insurers, health care providers, HMOs, pharmaceutical companies and
policy analysts. Therefore, the commercial potential of making survey data
more accessible is quite large. The purpose of this FOA is to encourage small
businesses to develop the areas listed below via the STTR (R41/R42) mechanisms.
The following list presents examples of such topics. This list
of topics is not comprehensive, nor are the examples exhaustive.

Survey Development/Archiving

Develop and/or archive highly user-friendly public use
data files from population-based household surveys and behavioral interventions
in order to make these data available to a wide range of users. Suggestions
include developing search and extraction software, graphical user interfaces,
querying approaches, and data retrieval and data integration methods.
These data sets proposed for development and/or archiving should be of national
significance and relate to the NIA/BSR priority areas of (1) Health Disparities;
(2) Aging Minds; (3) Increasing Health Expectancy; (4) Health,
Work, and Retirement; (5) Interventions and Behavior Change; (6) Genetics, Behavior,
and the Social Environment; and (7) The Burden of Illness and the Efficiency
of Health Systems. (See BSR Areas of Emphasis at http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/
).

Develop didactic user files as well as analytic and
statistical tools and programs for the study of large and complex datasets
by undergraduate and graduate students.

Develop, enhance and/or assemble new databases from
existing data.

Examples of population-based surveys and behavioral interventions
of priority to the NIA include: the Health and Retirement Study (HRS),
English Longitudinal Study of Aging (ELSA), National Social Life, Health and
Aging Project (NSHAP), National Health and Nutrition Examination Survey (NHANES),
National Survey of Midlife Development in the United States (MIDAS), Wisconsin
Longitudinal Study (WLS), The Whitehall II Study, The National Long-term Care
Survey (NLTCS), Panel Study of Income Dynamics (PSID), Social Environment
and Biomarkers of Aging Study (SEBAS), the World Health Organization’s Survey
of Global Aging (SAGE), the International Networks for the Continuous
Demographic Evaluation of Populations and their Health in Developing Countries
(INDEPTH), Resources for Enhancing Alzheimer’s Caregiver Health (REACH), and
Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE). See
http://www.nia.nih.gov/NR/rdonlyres/7AE4D0D9-9DF7-4DF4-B8B9-468F19106E23/0/PubliclyAvailDatasetsJul_2006B.pdf
for descriptions of many of these and other studies.

This funding opportunity will use the Small Business
Technology Transfer (STTR [R41/R42] grant mechanisms. Applications may be
submitted for support as Phase I, Phase II, or Fast-Track grants as described
in the SF424 (R&R) SBIR/STTR Application Guide.

Applicants may not simultaneously
submit identical/essentially identical applications under both this funding
opportunity and another HHS FOA, including the current parent SBIR or STTR
FOAs.

Phase II applications in response to this funding
opportunity will only be accepted as competing renewals (formerly “competing
continuations”) of previously funded Phase I STTR awards. The Phase II must
be a logical extension of the Phase I research but not necessarily as a Phase
I project supported in response to this funding opportunity.

The applicant SBC will be solely responsible for planning, directing, and
executing the proposed project. Future unsolicited, competing renewal applications
based on this project will compete with all STTR applications and will be
reviewed according to the customary peer review procedures. Applications that
are not funded in the competition described in this FOA may be submitted as
RESUBMISSION applications throughGrants.gov/Applyusing the standard NIH, CDC, and FDA submission dates
of April 1, August 1, and December 1 (or January 2, May 1, and September 1
for AIDS and AIDS-related STTR applications).

This funding opportunity uses just-in-time
concepts. The modular budget format is no longer accepted for STTR grant applications.
Applicants must complete and submit budget requests using the SF424
Research and Related (R&R) Budget component found in the application package
attached to this FOA in Grants.gov/Apply.

2. Funds Available

The SF424 (R&R) SBIR/STTR Application
Guide indicates the statutory guidelines of funding support and project
duration periods for Phase I and Phase II STTR awards.

Because the nature and scope of the proposed research will
vary from application to application, it is anticipated that the size and
duration of each award will also vary. The total amount awarded and the number
of awards will depend upon the mechanism, numbers, quality, duration and costs
of the applications received.

All awards are subject to the availability of funds.

Section III.
Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Only United States small business concerns (SBCs)
are eligible to submit STTR applications. A small business concern is one
that, at the time of award for both Phase I and Phase II awards, meets all
of the following criteria:

Is independently owned and operated, is not dominant in the field of operation
in which it is proposing, has a place of business in the United States and
operates primarily within the United States or makes a significant contribution
to the US economy, and is organized for profit.

Is at least 51% owned and controlled by one or more individuals who are
citizens of, or permanent resident aliens in, the United States.

Has, including its affiliates, an average number of employees for the preceding
12 months not exceeding 500, and meets the other regulatory requirements found
in 13 C.F.R. Part 121. Business concerns are generally considered to be affiliates
of one another when either directly or indirectly, (a) one concern controls
or has the power to control the other; or (b) a third-party/parties controls
or has the power to control both.

Control can be exercised through common ownership, common
management, and contractual relationships. The term "affiliates"
is defined in greater detail in Title 13 Code of Federal Regulations (CFR)
Part 121.103. The term "number of employees" is defined in 13 CFR
121.106.

A business concern may be in the form of an individual
proprietorship, partnership, limited liability company, corporation, joint
venture, association, trust, or cooperative. Further information may be obtained
at http://sba.gov/size, or by contacting the Small
Business Administration's (SBA) Government Contracting Area Office or Office
of Size Standards.

One of the circumstances that would lead to a finding that
an organization is controlling or has the power to control another organization
involves sharing common office space and/or employees and/or other facilities
(e.g., laboratory space). Access to special facilities or equipment in another
organization is permitted (as in cases where the awardee organization has
entered into a subcontractual agreement with another organization for a specific,
limited portion of the research project). However, research space occupied
by an STTR awardee organization must be space that is available to and under
the control of the STTR awardee for the conduct of its portion of the proposed
project.

Title 13 C.F.R. 121.3 also states that control or the power
to control exists when “key employees of one concern organize a new concern ...
and serve as its officers, directors, principal stockholders, and/or key employees,
and one concern is furnishing or will furnish the other concern with subcontracts,
financial or technical assistance, and/or other facilities, whether for a
fee or otherwise.” Where there is indication of sharing of common employees,
a determination will be made on a case-by-case basis of whether such sharing
constitutes control or the power to control.

For purposes of the STTR program, personnel obtained through
a Professional Employer Organization or other similar personnel leasing company
may be considered employees of the awardee. This is consistent with SBA’s
size regulations, 13C.F.R. 121.106 – Small Business Size Regulations.

All STTR grant applications will be examined with the above
eligibility considerations in mind. If it appears that an applicant organization
does not meet the eligibility requirements, NIH will request a size determination
by the SBA. If eligibility is unclear, NIH will not make an STTR award until
the SBA provides a determination.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources
necessary to carry out the proposed research is invited to work with their
organization to develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

For a STTR application, the Project Director/Principal Investigator (PD/PI)
may be employed with the SBC or the participating non-profit research institution
as long as s/he has a formal appointment with or commitment to the applicant
SBC.

As defined in Title 42 Code of Federal Regulations (CFR)
Part 52, the PD/PI is the “single individual designated by the grantee in
the grant application … who is responsible for the scientific and technical
direction of the project.” When the proposed PD/PI clearly does not have sufficient
qualifications to assume this role, the application is not likely to receive
a favorable evaluation.

The PD/PI must commit a minimum of 10% effort to the project
and the PD/PI must have a formal appointment with or commitment to the applicant
SBC, which is characterized by an official relationship between the SBC and
that individual. Such a relationship does not necessarily involve a salary
or other form of remuneration. In all cases, however, the PD/PI’s official
relationship with the grantee must entail sufficient opportunity for the PD/PI
to carry out his or her responsibilities for the overall scientific and technical
direction of the project. Documentation (e.g., consultant, consortium and
contractual arrangements) describing the official relationship of the PD/PI
with the applicant small business concern should NOT be submitted with the
grant application, but a copy must be furnished upon the request of the NIH
awarding component.

The following are examples of situations describing the
official relationship of the PD/PI with the applicant small business organization:

PD/PI with a full-time, university appointment may also
have appointments with other organizations (with or without salary) and
still appropriately consider his or her commitment to the university to
be “full-time,” consistent with the personnel policies and procedures of
the university applied on a routine basis. The PD/PI’s commitment to the
university and other organizations (including the applicant small business
concern) cannot exceed 100% of his or her total professional effort.

PD/PI with a full-time, 12-month appointment with a
small business concern would be considered to have a commitment to the applicant
organization of 100% of his or her total professional effort.

PD/PI who has a part-time appointment with a small business
concern and has concurrent commitments or appointments with organizations
in addition to the small business concern would deem each commitment as
a portion of 100% of his or her total professional effort.

In STTR Phase I and Phase II, at least 40% of the work must be performed by
the small business concern and at least 30% of the work must be performed
by the single, “partnering” research institution. The basis for determining
the percentage of work to be performed by each of the cooperative parties
will be the total of direct and F&A/indirect costs attributable to each
party, unless otherwise described and justified in Item 12, “Consortium/Contractual
Arrangements,” of the PHS398 Research Plan component of the SF424 (R&R)
application forms.

The NIH will accept as many "different"
applications as the applicant organization chooses. However, the NIH will
not accept similar grant applications with essentially the same research focus
from the same applicant organization. This includes derivative or multiple
applications that propose to develop a single product, process or service
that, with non-substantive modifications, can be applied to a variety of purposes.
Applicants may not simultaneously submit identical/essentially identical applications
under both this funding opportunity and another HHS FOA, including the current
parent SBIR or STTR FOAs.

Section IV. Application and Submission
Information

To download a SF424 (R&R) Application
Package and SF424 (R&R) SBIR/STTR Application Guide for completing the
SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

The individual designated as the PD/PI on the application
must also be registered in the NIH eRA Commons. It is not necessary for
PDs/PIs to register with Grants.gov.

The PD/PI must hold a PD/PI account in the Commons and
must be affiliated with the applicant organization. This account cannot
have any other role attached to it other than the PD/PI.

This registration/affiliation must be done by the Authorized
Organization Representative/Signing Official (AOR/SO) or their designee
who is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in
the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with
an Individual DUNS and CCR registration, that particular DUNS number and CCR
registration are for the individual reviewer only. These are different than
any DUNS number and CCR registration used by an applicant organization. Individual
DUNS and CCR registration should be used only for the purposes of personal
reimbursement and should not be used on any grant applications submitted to
the Federal Government.

Several of the steps of the registration process could
take four weeks or more. Therefore, applicants should immediately check with
their business official to determine whether their institution is already
registered in both Grants.gov and the
Commons. The NIH will accept electronic
applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application
forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly
attached to a specific FOA can be used. You will not be able to use any other
SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although
some of the "Attachment" files may be useable for more than one
FOA.

The SF424 (R&R) Application Guide is critical to submitting
a complete and accurate application to NIH. There are fields within the SF424
(R&R) application components that, although not marked as mandatory, are
required by NIH (e.g., the “Credential” log-in field of the “Research &
Related Senior/Key Person Profile” component must contain the PD/PI’s assigned
eRA Commons User ID). Agency-specific instructions for such fields are
clearly identified in the Application Guide. For additional information, see
“Tips and Tools for Navigating Electronic Submission” on the front page of
“Electronic Submission of
Grant Applications.”

The SF424 (R&R) application is comprised of data arranged
in separate components. Some components are required, others are optional.
The forms package associated with this FOA in Grants.gov/
APPLY will include all applicable components, required and optional.
A completed application in response to this FOA will include the following
components:

Applications in response to this FOA may only be submitted
to Grants.gov through Grants.gov/Apply.PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must
be successfully received by Grants.gov
no later than 5:00 p.m. local time (of the applicant institution/organization) on
the application submission/receipt date(s). (See Section
IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or
not reviewed.

Once an application package has been successfully submitted
through Grants.gov, any errors have been addressed, and the assembled application
has been created in the eRA Commons, the PD/PI and the Authorized Organization
Representative/Signing Official (AOR/SO) have two business days to view the
application image.

If everything is acceptable, no further action is necessary.
The application will automatically move forward for processing by the Division
of Receipt and Referral, Center for Scientific Review, NIH, after two business
days.

Prior to the submission deadline, the AOR/SO can “Reject”
the assembled application and submit a changed/corrected application within
the two day viewing window. This option should be used if the AOR/SO determines
that warnings should be addressed. Reminder: warnings do not stop further
application processing. If an application submission results in warnings
(but no errors) it will automatically move forward after two business days
if no action is taken. Please remember that some warnings may not
be applicable or may need to be addressed after application submission.

If the two day window falls after the submission deadline,
the AOR/SO will have the option to “Reject” the application if, due to an
eRA Commons or Grants.gov system issue, the application does not correctly
reflect the submitted application package (e.g., some part of the application
was lost or didn’t transfer correctly during the submission process). The
AOR/SO should first contact the eRA Commons Helpdesk to confirm
the system error, document the issue, and determine the best course of action.
NIH will not penalize the applicant for an eRA Commons or Grants.gov system
issue.

If the AOR/SO chooses to “Reject” the image after the
submission deadline for a reason other than an eRA Commons or Grants.gov
system failure, a changed/corrected application still can be submitted but
it will be subject to the NIH
late policy guidelines and may not be accepted. The reason for this
delay should be explained in the cover letter attachment.

Both the AOR/SO and PD/PI will receive e-mail notifications
when the application is rejected or the application automatically moves
forward in the process after two days.

Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review (CSR), NIH.
Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the assignment
of an application to a Scientific Review Group is also in the Commons.

The NIH will not accept any application
in response to this FOA that is essentially the same as one currently pending
initial merit review unless the applicant withdraws the pending application.
The NIH will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of an application
already reviewed with substantial changes, but such application must include
an “Introduction” addressing the previous critique. Note such an application
is considered a "resubmission" for the SF424 (R&R).

All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement.

Pre-Award Costs are allowable. A grantee may,
at its own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new or competing renewal award if such costs: are necessary to
conduct the project, and would be allowable under the grant, if awarded, without
NIH prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost.
NIH prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or competing
renewal award.

The incurrence of pre-award costs in anticipation
of a competing or non-competing award imposes no obligation on NIH either
to make the award or to increase the amount of the approved budget if an award
is made for less than the amount anticipated and is inadequate to cover the
pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award
costs result in borrowing against future support and that such borrowing must
not impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants
Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her
Commons User ID in the “PROFILE – Project Director/Principal Investigator”
section, “Credential” log-in field of the “Research & Related Senior/Key
Person Profile” component. The applicant organization must include its DUNS
number in its Organization Profile in the eRA Commons. This DUNS number must
match the DUNS number provided at CCR registration with Grants.gov. For additional
information, see “Tips and Tools for Navigating Electronic Submission” on
the front page of “Electronic Submission of Grant Applications

All application instructions outlined in the SF424 (R&R)
SBIR/STTR Application Guide (MS
Word or PDF)
are to be followed, with the following requirements.

STTR Phase I applications:

Although preliminary data are not required, they may be included.

Items 2-5 of the Research Plan component may not exceed 15 pages, including
tables, graphs, figures, diagrams, and charts.

“Introduction” (required for a resubmission application) is limited to one
(1) page.

The Biographical Sketch is limited to a maximum of 4 pages for
each senior/key person. (This includes the table at the top of the first page).

There is no further limitation on the total number of pages for the entire
Phase I application; however, applicants are encouraged to be succinct.

STTR Phase II applications:

Items 2-5 of the Research Plan component may not
exceed 25 pages, including tables, graphs, figures, diagrams, and charts.

“Introduction” (required for a resubmission application) is limited to three
(3) pages.

The Biographical Sketch is limited to a maximum of four (4) pages
for each senior/key person. (This includes the table at the top of the first
page).

The Phase II application must present a Commercialization Plan (maximum
15 pages) that addresses specific points as described in the SF424 (R&R)
SBIR/STTR Application Guide and the SBIR/STTR Information component.

There is no further limitation on the total number of pages for the entire
Phase II application; however, applicants are encouraged to be succinct.

STTR Fast-Track applications:

Unlike in the past where Fast-Track applicants were
required to submit two separate applications (one for Phase I and one for
Phase II), the NIH Fast-Track application is now a single application consisting
of Phase I and Phase II activities. See the SF424 (R&R) SBIR/STTR Application
Guide.

The Phase I portion of a Fast-Track must specify clear, measurable goals
(milestones) that should be achieved prior to initiating Phase II work.

The Fast-Track application must present a Commercialization Plan (maximum
15 pages) that addresses specific points as described in the SF424 (R&R)
SBIR/STTR Application Guide.

“Introduction” (required for a resubmission application) is limited to three
(3) pages.

Items 2-5 of the Research Plan may not exceed 25 pages. That is, the combined
Phase I and Phase II plans for Fast-Track applications (for Items 2-5) must
be contained within the 25-page limitation.

Note: While each section of the Research Plan needs to eventually
be uploaded separately as a PDF attachment, applicants are encouraged to construct
the Research Plan as a single document, separating sections into distinct
PDF attachments just before uploading the files. This approach will enable
applicants to better monitor formatting requirements such as page limits.

Plan for Sharing Research Data

Applicants requesting $500,000 or more in direct
costs in any year should include a brief one paragraph description of how
final research data will be shared, or explain why data-sharing is not possible.
The specific nature of the data to be collected will determine whether or
not the final dataset may be shared. If the final data are not amenable to
sharing, for example, if they are proprietary, this must be explained in the
application. The Small Business Act requires NIH to protect from disclosure
and nongovernmental use all SBIR and STTR data developed from work performed
under an SBIR and STTR funding agreement for a period of four (4) years after
the closeout of either a Phase I or Phase II grant unless NIH obtains permission
from the awardee to disclose these data. The data rights protection period
lapses only upon expiration of the protection period applicable to the SBIR
and STTR award, or by agreement between the small business concern and NIH.
Applicants are encouraged to discuss their data-sharing plan with the Institute/Center
(IC) staff likely to accept assignment of their application.

The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score. For more information
on data sharing see https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(See FAQ #13.)

The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3. Reporting.

Section V. Application Review
Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will
be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established PHS referral guidelines.

Undergo a selection process in which only those applications
deemed to have the highest scientific merit, generally the top half of applications
under review, will be discussed and assigned a priority score.

Receive a written critique.

Receive a second level of review by the appropriate advisory council or board.

Applications submitted in response
to this funding opportunity will compete for available funds with all other
recommended STTR applications. The following will be considered in making
funding decisions:

Scientific merit of the proposed project as determined
by peer review.

Availability of funds.

Relevance to program priorities.

The goals of NIH-supported research
are to advance our understanding of biological systems, improve the control
of disease, and enhance health. In the written comments, reviewers will be
asked to discuss the following aspects of the application in order to judge
the likelihood that the proposed research will have a substantial impact on
the pursuit of these goals. The scientific review group will address and consider
each of these criteria in assigning the application's overall score, weighting
them as appropriate for each application.

Significance

Approach

Innovation

Investigator

Environment

Additional Review Criteria

The application does not need to
be strong in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score.

All STTRApplications

Significance: Does the proposed project have
commercial potential to lead to a marketable product, process, or service?
Does this study address an important problem? What may be the anticipated
commercial and societal benefits that may be derived from the proposed research?
If the aims of the application are achieved, how will scientific knowledge
or clinical practice be advanced? What will be the effect of these studies
on the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Does the application lead to enabling
technologies (e.g., instrumentation, software) for further discoveries? Will
the technology have a competitive advantage over existing/alternate technologies
that can meet the market needs?

Approach: Are the conceptual or clinical framework,
design, methods, and analyses adequately developed, well-integrated, and appropriate
to the aims of the project? Is the proposed plan a sound approach for establishing
technical and commercial feasibility? Does the applicant acknowledge potential
problem areas and consider alternative strategies? Are the milestones and
evaluation procedures appropriate?

Innovation: Are the aims original and innovative?
Does the project challenge existing paradigms or clinical practice; address
an innovative hypothesis or critical barrier to progress in the field? Does
the project develop or employ novel concepts, approaches, methodologies, tools,
or technologies for this area?

Investigator: Is the PD/PI appropriately trained
and capable of coordinating and managing the proposed STTR? Are the investigators
well suited to carry out this work? Does the investigative team bring complementary
and integrated expertise to the project (if applicable)? Is the work proposed
appropriate to the experience level of the PD/PI and other researchers, including
consultants and subcontractors (if any)? Are the relationships of the key
personnel to the small business and to other institutions appropriate for
the work proposed?

Environment: Is there sufficient access to
resources (e.g., equipment, facilities)? Does the scientific and technological
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative arrangements?
Is there evidence of institutional support?

Phase II ApplicationsIn addition to the above review criteria:

1. How well did the applicant demonstrate progress
toward meeting the Phase I objectives, demonstrating feasibility, and providing
a solid foundation for the proposed Phase II activity?

2. Did the applicant submit a concise Commercialization
Plan that adequately addresses the specific areas described in the SF424 (R&R)
SBIR/STTR Application Guide and the SBIR/STTR Information component?

3. Does the project carry a high degree of commercial
potential, as described in the Commercialization Plan?

Resubmission Applications(formerly
“amended” applications)

In addition to the above criteria,
the following criteria will be applied to resubmission applications.

1. Are the responses to comments from the previous
scientific review group adequate?

2. Are the improvements in the resubmission application
appropriate?

Phase I/Phase II Fast-Track Application Review
Criteria

For Phase I/Phase II Fast Track applications,
the following criteria also will be applied:

1. Does the Phase I application specify clear, appropriate,
measurable goals (milestones) that should be achieved prior to initiating
Phase II?

2. Did the applicant submit a concise Commercialization
Plan that adequately addresses the specific areas described in the SF424 (R&R)
SBIR/STTR Application Guide and the SBIR/STTR Information component?

3. To what extent was the applicant able to obtain
letters of interest, additional funding commitments, and/or resources from
the private sector or non-SBIR/STTR funding sources that would enhance the
likelihood for commercialization?

4. Does the project carry a high degree of commercial
potential, as described in the Commercialization Plan?

Phase I and Phase II Fast-Track applications that
satisfy all of the review criteria will receive a single rating.

For Fast-Track applications, the Phase II portion
may not be funded until a Phase I final report and other documents necessary
for continuation have been received and assessed by program staff that the
Phase I milestones have been successfully achieved. Items 2-5 of the Research
Plan may not exceed 25 pages. That is, the combined Phase I and Phase II plans
for a Fast-Track application (for Items 2-5) must be contained within the
25-page limitation.

2.A. Additional Review Criteria:

In addition to the above criteria, the following
items will continue to be considered in the determination of scientific merit
and the priority score:

Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed. See item
6 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five
items described under item 11 of the Research Plan component of the SF424
(R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the proposed
protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed research
may be assessed by the reviewers. Is the effort listed for the PD/PI appropriate
for the work proposed? Is each budget category realistic and justified in
terms of the aims and methods?

Period of Support: The appropriateness of the
requested period of support in relation to the proposed research.

Program staff will be responsible for the administrative
review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making recommendations
about funding applications. Program staff may negotiate modifications of the
data and resource sharing plans with the awardee before recommending funding
of an application. The final version of the data and resource sharing plans
negotiated by both will become a condition of the award of the grant. The
effectiveness of the resource sharing will be evaluated as part of the administrative
review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration
Information

1. Award Notices

After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA Commons.

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization
to begin performance. Any costs incurred before receipt of the NoA are at
the recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See also Section IV.5.,
“Funding Restrictions.”

We encourage your inquiries concerning
this funding opportunity and welcome the opportunity to answer questions from
potential applicants. Inquiries may fall into three areas: scientific/research,
peer review, and financial or grants management issues:

Human Subjects Protection:Federal regulations (45 CFR 46) require that applications
and proposals involving human subjects must be evaluated with reference to
the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
(“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and
Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include
a plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions
on issues related to institutional policies and local IRB rules, as well as
local, state, and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the plan
into the determination of scientific merit or the priority score.

Access to Research Data through the Freedom of
Information Act:The OMB Circular A-110 has been revised to provide
access to research data through the Freedom of Information Act (FOIA) under
some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through the FOIA. It
is important for applicants to understand the basic scope of this amendment.
NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure informed
consent statements and other human subjects procedures given the potential
for wider use of data collected under this award.

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time, the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statementhttps://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
Beginning October 1, 2004, all investigators submitting an NIH application
or contract proposal are expected to include in the application/proposal a
description of a specific plan for sharing and distributing unique model organism
research resources generated using NIH funding or state why such sharing is
restricted or not possible. This will permit other researchers to benefit
from the resources developed with public funding. The inclusion of a model
organism sharing plan is not subject to a cost threshold in any year and is
expected to be included in all applications where the development of model
organisms is anticipated.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key personnel.
The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria for Federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp
and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.

NIH Public Access Policy:NIH-funded investigators are requested to submit to
the NIH Manuscript Submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.

NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.

Standards for Privacy of Individually Identifiable
Health Information:The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:All applications and proposals for NIH funding must
be self-contained within specified page limitations. Unless otherwise specified
in an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.

Healthy People 2010:The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This FOA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the
Catalog of Federal Domestic Assistance at http://www.cfda.gov/
and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42 USC
241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts
74 and 92. All awards are subject to the terms and conditions, cost principles,
and other considerations described in the NIH Grants Policy
Statement.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the American
people.

Loan Repayment Programs:NIH encourages applications for educational loan repayment
from qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception, infertility,
and health disparities related areas. The LRP is an important component of
NIH's efforts to recruit and retain the next generation of researchers by
providing the means for developing a research career unfettered by the burden
of student loan debt. Note that an NIH grant is not required for eligibility
and concurrent career award and LRP applications are encouraged. The periods
of career award and LRP award may overlap providing the LRP recipient with
the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov.